A5034572745- Pneumonia and Respiratory Infections
- Bacterial Infections and Vaccines
- Respiratory viral infections research
- Pneumocystis jirovecii pneumonia detection and treatment
- SARS-CoV-2 and COVID-19 Research
- Influenza Virus Research Studies
- HIV/AIDS drug development and treatment
- Chronic Lymphocytic Leukemia Research
- Immunodeficiency and Autoimmune Disorders
- HIV-related health complications and treatments
- Vaccine Coverage and Hesitancy
Pfizer (United States)
2020-2023
Pneumococcal conjugate vaccines (PCVs) have significantly reduced pneumococcal disease, but disease from non-PCV serotypes remains. The safety, tolerability, and immunogenicity of a 20-valent PCV (PCV20) were evaluated.
Older adults are at increased risk of adverse outcomes from pneumococcal disease and influenza infections. Vaccination is an established strategy for preventing both illnesses. This study evaluated coadministration 20-valent conjugate vaccine (PCV20) adjuvanted quadrivalent inactivated (QIV). phase 3, randomized, double-blind, multicenter included 1796 US ≥ 65 years age randomized 1:1 to receive either PCV20 QIV followed 1 month later by saline (Coadministration group) or (Separate...
Abstract Background PCV20 contains the 13-valent pneumococcal conjugate vaccine (PCV13) components, and 7 additional conjugates (for serotypes 8, 10A, 11A, 12F, 15B, 22F, 33F), extending serotype coverage. Key data from pivotal Phase 3 evaluation of in adults are presented. Methods Adults naïve to vaccination were enrolled into age cohorts (≥60, 50–59, 18–49 years age). Participants ≥60 received either saline 1 month later, or PCV13 23-valent polysaccharide (PPSV23) later (1:1 randomization,...
The aim of this post hoc analysis was to describe the immunogenicity 20-valent pneumococcal conjugate vaccine (PCV20) in adults with chronic medical conditions or smoking that place them at increased risk developing disease. Data from 2 phase 3, randomized, active-controlled, double-blind studies vaccine-naive were analyzed. Study 1: ≥18 years enrolled 1 3 age-based cohorts (18‒49, 50‒59, and ≥60 years) randomized (1:1, years; 3:1, younger cohorts) receive dose PCV20 13-valent PCV (PCV13)....
Abstract Background A variant-adapted bivalent BNT162b2 mRNA vaccine (bivalent BNT162b2) comprising original SARS-CoV-2 and Omicron BA.4/BA.5 spike proteins is authorized by the US FDA from 6 months of age as a primary series or booster doses. We studied whether generates improved immune responses against ancestral strains had comparable safety profile to in 5–11-year-olds. Methods This substudy part phase 1/2/3 master study (NCT05543616) examining immunogenicity healthy children. The group...
Abstract Background A variant-adapted bivalent BNT162b2 vaccine (bivalent BNT162b2) comprised of original SARS-CoV-2 and Omicron BA.4/BA.5 spike proteins was developed to improve protection against variants. Bivalent is authorized by the US FDA from 6 months (mo) old; for children mo < 5 years (y), it as a 3-dose primary series fourth dose (first booster). Methods This substudy part phase 1/2/3 master study (NCT05543616) investigating safety immunogenicity BNT162b2. The group reported...